Email, pen drive or Google Drive only – the country’s top drugs regulator will stop accepting paper documents to grant approvals and manufacturing licenses for medicines, devices and vaccines, News18 has learned.
In a bid to promote “Digital India”, the Central Drugs Standard Control Organization (CDSCO) has asked its offices across India to “accept electronic copies only”. The new regulations will come into effect on February 1.
On January 25, the regulatory agency “issued a notice requiring all offline applications in districts, divisions, ports, and laboratories to be processed from physical files to electronic files to ensure the smooth and efficient operation of CDSCO’s electronic office.”
According to the latest notification obtained by News18, “All applicants or stakeholders are required to submit applications, bulk files, documents, query responses, etc. in soft copies…”
Many state and central government agencies are transitioning to digital processes with the aim of increasing transparency in day-to-day operations. The shift was made in response to challenges such as misplaced files and duplicate documents being created for the same problem.
For example, the Comptroller and Auditor General (CAG) of India announced on April 1 last year that all audit operations across India would shift to digital platforms. It eliminates the need for physical documentation across 130 offices. This development ensures seamless record keeping without the burden of managing large volumes of physical files, while maintaining transparency and permanent records.
All functionality moved to digital app
The notification explains that the rule applies to submission of applications or documents related to World Health Organization Good Manufacturing Practices (WHO-GMP), private testing laboratories, manufacturing licenses, blood banks, vaccines, DNA forms, veterinary medicinal products and other miscellaneous applications Stakeholders – covers most moderator functions.
The order clarifies that new submissions should be made via pen drive or Google Drive. “Large volumes of archives, documents, responses to inquiries etc. may also be forwarded via email in the form of scanned copies, preferably in pdf format of less than 20 MB,” it said.
“Effective February 1, 2024, the office will no longer accept hard copies of applications,” the order said.
“All manufacturers or stakeholders can ensure that applications are submitted strictly electronically, otherwise their applications will not be accepted or processed further,” the notification said, while adding, “Collaboration in the implementation of e-office to promote Digital India A warm welcome.”
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